Author(s):
Hema B, Anjali Nayak, Sangeetha G, Rosita ruth Carlota, Maria Danish Alwin, Paramita Das
Email(s):
hemabyrappa4@gmail.com , anjaliangel84.pharma@gmail.com , sange2008@gmail.com , rositacarlota99@gmail.com , allwinrobert22@gmail.com , paramitadas04@gmail.com
DOI:
10.52711/0974-360X.2024.00685 
Address:
Hema B1, Anjali Nayak2*, Sangeetha G1, Rosita ruth Carlota1, Maria Danish Alwin1, Paramita Das2
1Department of Quality Assurance, Krupanidhi College of Pharmacy, Bengaluru, Karnataka – 560035.
2Department of Pharmaceutical Chemistry, Krupanidhi College of Pharmacy, Bengaluru, Karnataka – 560035.
*Corresponding Author
Published In:
Volume - 17,
Issue - 9,
Year - 2024
ABSTRACT:
The use of analytical quality by design (AQbD) process in the optimization of the high-performance liquid chromatography (RP-HPLC) method is a novel tool. The major stages of AQbD such as Risk assessment, Designing of Experiments (DOE) and Development of Method Operable Design Region (MODR) methodology are explained in detail. Factors like flow rate, column length and buffer and responses like retention time, tailing, peak area were selected to create a custom experiment design that was utilised for Epalrestat method analysis and optimisation. The optimized HPLC condition was found as NaH2PO4: Methanol (10: 90%v/v), flow rate (1.1ml/min), and UV wave length (240nm). It gives the retention time of 2.877 min with the linearity range of 50–150 µg/ml with a high regression value (r 2 = 1), and %recovery was found to be 100%. Sensitivity evaluation revealed limit of detection and limit of quantification were found to be 0.082 µg/ml and 0.2µg/ml respectively. The method was found to be precise and accurate with low % RSD of 0.2%, degradation studies were carried as per ICH Q2R1. Prediction profiler and contour plots by custom design which also confirms the robustness of the method.
Cite this article:
Hema B, Anjali Nayak, Sangeetha G, Rosita ruth Carlota, Maria Danish Alwin, Paramita Das. A new RP-HPLC Method Development, Validation and Stability-Indicating Studies of Epalrestat in Bulk Drug by Analytical Quality by Design Approach. Research Journal of Pharmacy and Technology. 2024; 17(9):4437-2. doi: 10.52711/0974-360X.2024.00685
Cite(Electronic):
Hema B, Anjali Nayak, Sangeetha G, Rosita ruth Carlota, Maria Danish Alwin, Paramita Das. A new RP-HPLC Method Development, Validation and Stability-Indicating Studies of Epalrestat in Bulk Drug by Analytical Quality by Design Approach. Research Journal of Pharmacy and Technology. 2024; 17(9):4437-2. doi: 10.52711/0974-360X.2024.00685 Available on: https://rjptonline.org/AbstractView.aspx?PID=2024-17-9-46
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